Leep Precision™ Integrated System
LEEP PRECISION™ Integrated System (230 VAC)
6manufacturers in China registered for this device type
2catalogue numbers in this listing
1510(k) clearance
22recalls on this code
Who Else Makes It
Concentrated in Guangdong (3), Zhejiang (3). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Modern Medical Equipment Manufacturing Ltd. | Heng Li, Dongguan | Guangdong | Contract manufacturer | 26 |
| Zhejiang Shuyou Surgical Instrument Co., Ltd. | Huzhou | Zhejiang | Contract manufacturer | 13 |
| Ningbo Shun YE Medical Company, Ltd. | Cixi Ningbo | Zhejiang | Contract manufacturer | 8 |
| Modern Medical Equipment Manufacturing (Qing Yuan) Ltd | Qing Yuan | Guangdong | Contract manufacturer | 26 |
| Shenzhen JPY ION-Tech. Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 20 |
| Zhejiang Jinhua Huatong Medical Appliance Co., Ltd. | Jinhua | Zhejiang | Manufacturer | 4 |
Record
| Listed by | Coopersurgical, Inc., United States |
|---|---|
| FDA product code | HGI |
| Device type | Electrocautery, Gynecologic (And Accessories) |
| Device class | Class 2 |
| Regulation | 21 CFR 884.4120 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K963348 |
| Record published | 2023-01-04 |
| Record revised | 2024-02-28 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| LP-10-220 | In distribution | |
| LP-10-120 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Bovie | Aspen Surgical Products, Inc. | 138 |
| DeRoyal | Deroyal Industries, Inc. | 27 |
| Electrocautery, Gynecologic (And Accessories) | C R I | 24 |
| Greenwald Surgical Company, Inc. | Grace Manufacturing Inc | 22 |
| Valleylab | Aspen Surgical Products, Inc. | 20 |
| Argent | Mckesson Medical-Surgical Inc. | 19 |
| Carrera Loop Electrodes | Gynex Corporation | 19 |
| Weck | Teleflex Medical LLC | 18 |
| Radius Loop ELectrodes | Gynex Corporation | 13 |
| Aesculap | Aesculap AG | 11 |
| Leep Radius Electrode | Coopersurgical, Inc. | 10 |
| Premier | Premier Dental Products Co. | 9 |
Showing 12 of 70. All products under Electrocautery, Gynecologic (And Accessories)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K952483 | 1995-10-06 |
Recalls Naming This Product
4 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Coopersurgical, Inc. | 510(k) number | 2021-09-29 | Class II | Component design/selection | Coagulate function may not operate with the use of the Hand Switch, failure of the device to coagulate tissue may lead to a prolonged procedure requiring medical intervention to control any intraoperative bleeding and complete the case. | 1587 Units | |
| Coopersurgical, Inc. | 510(k) number | 2021-09-29 | Class II | Component design/selection | Coagulate function may not operate with the use of the Hand Switch, failure of the device to coagulate tissue may lead to a prolonged procedure requiring medical intervention to control any intraoperative bleeding and complete the case. | 75 Units | |
| Coopersurgical, Inc. | 510(k) number | 2019-06-18 | Class II | Device Design | The products’ cut, coagulate, or blend function may not operate with the use of the Foot Pedal. | 358 | 2020-06-15 |
| Coopersurgical, Inc. | 510(k) number | 2019-04-23 | Class II | Process control | 2.5A slow blow fuses may have been installed in the LEEP RPECISION Generator rather than the appropriate 3.15A slow blow fuses. | 19 | 2020-04-24 |
Recalls
10 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2021-09-29 | Class II | Component design/selection | Coagulate function may not operate with the use of the Hand Switch, failure of the device to coagulate tissue may lead to a prolonged procedure requiring medical intervention to control any intraoperative bleeding and complete the case. | 193 Units | |
| 2021-09-29 | Class II | Component design/selection | Coagulate function may not operate with the use of the Hand Switch, failure of the device to coagulate tissue may lead to a prolonged procedure requiring medical intervention to control any intraoperative bleeding and complete the case. | 244 Units | |
| 2021-09-29 | Class II | Component design/selection | Coagulate function may not operate with the use of the Hand Switch, failure of the device to coagulate tissue may lead to a prolonged procedure requiring medical intervention to control any intraoperative bleeding and complete the case. | 700 Units | |
| 2021-09-29 | Class II | Component design/selection | Coagulate function may not operate with the use of the Hand Switch, failure of the device to coagulate tissue may lead to a prolonged procedure requiring medical intervention to control any intraoperative bleeding and complete the case. | 75 Units | |
| 2021-09-29 | Class II | Component design/selection | XXX | 154 Units | |
| 2019-10-16 | Class II | Device Design | Potential for the Quantum 2000 Electrosurgery Generator, part numbers 909075, 909075-05 and 909075-05W, to cease to either cut, coagulate, or blend during a procedure when the foot pedal is used for activation. | 110 | 2020-06-30 |
| 2019-10-16 | Class II | Device Design | Potential for the Quantum 2000 Electrosurgery Generator, part numbers 909075, 909075-05 and 909075-05W, to cease to either cut, coagulate, or blend during a procedure when the foot pedal is used for activation. | 105 | 2020-06-30 |
| 2019-10-16 | Class II | Device Design | Potential for the Quantum 2000 Electrosurgery Generator, part numbers 909075, 909075-05 and 909075-05W, to cease to either cut, coagulate, or blend during a procedure when the foot pedal is used for activation. | 4 | 2020-06-30 |
| 2018-03-12 | Class II | Under Investigation by firm | Products have been packaged with an incorrect product size. | 500 | 2019-05-08 |
| 2014-10-27 | Class II | Packaging process control | Outer box is mislabeled as P/N R2010- Large Radius Loop Electrode instead of P/N R1010- Medium Radius Loop Electrode | 595 units | 2015-05-29 |
| 2006-03-10 | Not classified | Other | Change in product material may be cause for wire breaking, and tip burning and melting during procedure. Broken pieces of the device may need to be retrieved from patient. | 831.0 boxes | 2016-03-07 |
| 2006-03-10 | Not classified | Other | Change in product material may be cause for wire breaking, and tip burning and melting during procedure. Broken pieces of the device may need to be retrieved from patient. | 129.0 boxes (10 each) | 2016-03-07 |
| 2006-03-10 | Not classified | Other | Change in product material may be cause for wire breaking, and tip burning and melting during procedure. Broken pieces of the device may need to be retrieved from patient. | 1,845.0 boxes | 2016-03-07 |
| 2006-03-10 | Not classified | Other | Change in product material may be cause for wire breaking, and tip burning and melting during procedure. Broken pieces of the device may need to be retrieved from patient. | 2,813.0 boxes | 2016-03-07 |
| 2006-03-10 | Not classified | Other | Change in product material may be cause for wire breaking, and tip burning and melting during procedure. Broken pieces of the device may need to be retrieved from patient. | 129 boxes (10 each) | 2016-03-07 |
| 2006-03-10 | Not classified | Other | Change in product material may be cause for wire breaking, and tip burning and melting during procedure. Broken pieces of the device may need to be retrieved from patient. | 818.0 boxes | 2016-03-07 |
| 2006-03-10 | Not classified | Other | Change in product material may be cause for wire breaking, and tip burning and melting during procedure. Broken pieces of the device may need to be retrieved from patient. | 1,232.0 boxes | 2016-03-07 |
| 2006-03-10 | Not classified | Other | Change in product material may be cause for wire breaking, and tip burning and melting during procedure. Broken pieces of the device may need to be retrieved from patient. | 1,602.7 boxes | 2016-03-07 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.